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New Data on BPA Do Not Support Changing Tolerable Daily Intake, Says European Food Safety Authority

The European Food Safety Authority (EFSA) reviewed two studies by Ménard et al. (2014) at the request of the Dutch Ministry of Health, Welfare and Sport and concluded that they did not justify revising the temporary tolerable daily intake (t-TDI) for bisphenol A (BPA). EFSA conducted a comprehensive assessment of the risks to public health from exposure to BPA and published a scientific opinion in which it established a temporary TDI of 4 µg/kg bw/day in December 2014, before the studies by Ménard et al. were published.  EFSA proposed a temporary TDI due to uncertainty about certain effects of BPA in laboratory animals and committed to re-evaluating the safety of the compound when a two-year study on BPA being conducted by the U.S. National Toxicology Program is completed in 2017.   

EFSA’s expert Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), which conducted the review, found that while the two studies by Ménard et al. showed that BPA might affect the immune system in animals, limitations in the design and conduct of the studies prevent drawing any conclusions with respect to human health.  EFSA cited the use of a single dose for the majority of the tests as a particularly limiting factor.  

EFSA will consider all of the scientific evidence published after 2012 as part of a review it will begin in 2017 on the temporary TDI for BPA. Discussing the re-evaluation, Professor Vittorio Silano, CEF Chair, stated, “…additional immunological studies such as those by Ménard et al. would be useful contributions if the limitations we identified are addressed.” More information on EFSA’s response to the Dutch Ministry of Health, Welfare and Sport, can be found on EFSA’s website.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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